Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH

Launched by NEOTRACT, INC. · Jul 23, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for men with benign prostatic hyperplasia (BPH), a condition that causes urinary problems due to an enlarged prostate. The study will compare the Prostatic Urethral Lift procedure, which is a minimally invasive treatment that opens up the urethra, to a medication called tamsulosin, which helps relax the muscles around the prostate to improve urinary flow. About 250 men, aged 45 and older, will participate across 25 locations in the United States.

To join the study, men must be diagnosed with BPH and experience specific symptoms. They will need to stop taking their current BPH medications before starting the trial. Participants can expect to be randomly assigned to either the procedure or the medication group. They will also need to attend follow-up visits to monitor their progress. This trial is currently recruiting participants, and it aims to find out which treatment works better for relieving BPH symptoms.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male 45 years of age or older
• • 2. Diagnosis of BPH
• • 3. Experiencing symptoms of BPH as indicated by an IPSS ≥8 and ≤30
• • 4. Willing to wash out of current BPH medication(s), as applicable
• • 5. An appropriate candidate for both BPH therapies evaluated in this study.
• • 6. Ability to understand and consent to participate in this study
• • 7. Willing and able to participate in follow-up evaluations
• Exclusion Criteria:
• • 1. Use of alpha blocker for BPH unless washed-out for 30 days
• • 2. Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
• • 3. 5-alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
• • 4. Current urinary tract infection or prostatitis
• • 5. Current gross hematuria
• • 6. Urinary incontinence presumed due to incompetent sphincter
• • 7. Catheter-dependent urinary retention within 1 month prior to enrollment
• • 8. Prostate volume greater than 100 cc as measured by TRUS
• • 9. Prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out
• • 10. History of neurogenic or atonic bladder
• • 11. History prostate cancer treatment
• • 12. Known to be hypersensitive to tamsulosin HCl or any component of tamsulosin HCl capsules
• • 13. Known allergy to nickel, titanium, or stainless steel
• • 14. Prior minimally invasive or surgical intervention for BPH
• • 15. Urethral conditions that may prevent insertion of delivery system into bladder.
• • 16. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
• • 17. History of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject